Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on NEWRON PHARMACEUTICALS SPA. We currently have 5 research reports from 1 professional analysts.
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NEWRON PHARMACEUTICALS SPA
NEWRON PHARMACEUTICALS SPA
Xadago receives FDA approval in PD
22 Mar 17
Newron and its partners Zambon and US WorldMeds have announced that the FDA has approved Xadago (safinamide) for Parkinson’s disease (PD) patients as an add-on therapy to levodopa/carbidopa. While we had expected approval (following the revised PDUFA date of 21 March), the certainty of approval removes a major overhang on the stock, and as such we expect a positive share price reaction. We expect launch in the US market in H217 by sub licensee US WorldMeds. Our valuation of Newron remains unchanged at CHF530m.
Marching into 2017
13 Mar 17
We anticipate that the sales and pipeline progression made by Newron in 2016 will be cemented further in 2017/18. A critical catalyst remains the US Xadago (Parkinson’s disease (PD) therapy) approval which is imminent (revised PDUFA date is 21 March); this will materially impact the share price performance. We anticipate US launch in H217 by sub licensee, US WorldMeds. Data from pipeline assets sarizotan (Rett’s syndrome, RS) and evenamide (schizophrenia) in the upcoming 18 months will highlight Newron’s diverse, innovative CNS-based R&D portfolio. We value the company at CHF530m.
Xadago US approval slips out further
31 Mar 16
Newron has received a complete response letter from the FDA for its Parkinson’s disease drug Xadago (safinamide). Specifically, the FDA has requested clinical data on the potential effect of Xadago relating to abuse liability and dependence/withdrawal effects. No further efficacy or safety data for Xadago in patients with Parkinson’s disease has been requested. In next steps Newron will meet with Controlled Substance Staff (CSS) of the FDA to discuss exact requirements to address the issue. We anticipate that Newron will need to provide data relating to abuse liability and dependence in healthy subjects, and thus additional trials may be required. As such, we place our financial forecasts and valuation under review until we receive clarity on next steps and the potential impact on regulatory approval and market launch in the US
US partner on board ahead of PDUFA date
18 Mar 16
Commercial partner, Zambon, has announced a sublicence agreement with US WorldMeds for the US commercialisation of Parkinson’s disease (PD) therapy Xadago (safinamide). Under the agreement’s terms Zambon will give Newron a share of undisclosed, upfront milestone and royalty payments made by US WorldMeds, in addition to a milestone payment on FDA approval (we estimate €9m, not included in our forecasts). Importantly Xadago’s US PDUFA date is looming (29 March 2016) and a positive decision will clearly bode well for Newron’s share price. Our valuation of Newron remains unchanged at CHF504m or CHF35.5/share.
Xadago European roll-out continues
15 Mar 16
At its FY15 results Newron reported €0.5m (vs our €0.8m estimate) in royalties from commercial partner, Zambon after seven months of Xadago (Parkinson’s disease therapy) sales in Germany. So far in 2016 Zambon has also launched Xadago in Italy, Switzerland and Spain. The Xadago US PDUFA date is 29 March 2016, and a Xadago sublicensing deal in the US and a potential partnership for NW-3509 are on the cards. We have lowered our valuation slightly to CHF504m (vs CHF522m) primarily to reflect an increase in R&D expenses to support the mid-stage pipeline.
N+1 Singer - Morning Song 21-03-2017
21 Mar 17
accesso Technology (ACSO LN) Full year results in line, but key trading months still ahead | Augean (AUG LN) Double digit growth in ’16, good start to ‘17 | Earthport (EPO LN) Interims show continued top line strength | Goals Soccer Centres (GOAL LN) Good momentum under new team. It’s now all about delivery | IQE (IQE LN) FY’16 results prompt further upgrades | Microsaic Systems (MSYS LN) Challenges in 2016, strategy remains in place | mporium Group (MPM LN) Funds raised to help execute strategy | RhythmOne (RTHM LN) Dawn of the independents | ScS Group (SCS LN) Strong progress on key growth initiatives albeit comps now toughen | Sinclair Pharma (SPH LN) FY results: EBITDA ahead, Instalift™ gaining pace | Vectura Group (VEC LN) FY (9-month) results
N+1 Singer - Morning Song 22-03-2017
22 Mar 17
Carador Income Fund (CIFU LN) Premium rating restored, high levels of refinancing activity | Cello Group (CLL LN) Outlook getting brighter – watch Pulsar | Eckoh (ECK LN) Largest ever US secure payments win | eg solutions (EGS LN) Full year results in line | Futura Medical (FUM LN) Licensing deal for CSD500 in Portugal | Verona Pharma (VRP LN) Global agreement with QuintilesIMS to support development of RPL554 | Xaar (XAR LN) 2016 results slightly ahead, reduced visibility in 2017
Good results, but further restructuring complex for investors
20 Mar 17
EKF Diagnostics FY 2016 results are slightly ahead of expectations, with both higher revenue and better EBITDA. Management has also announced plans to split the company into two separate companies, Point of Care and Laboratory Diagnostics, with the prospect of a delisting to manage the process. The primary metric for valuation of the two businesses is different consequently we believe that the separation is likely to generate significant value. However, in anticipation of the volatility likely given the restructuring announced this morning, despite the strength of the results, we reduce our recommendation to HOLD and maintain our 21p target price.
N+1 Singer - EKF Diagnostics - Final results & potential buy back
20 Mar 17
FY16 prelims are slightly ahead of our latest expectations, those having been increased materially over the course of H2’16 as the strength of the recovery in trading became apparent. In order to maximise shareholder value, the directors are currently examining a potential break up of the group. This would also involve a delisting from AIM. A buy back offer at 21.5p would therefore be made to those investors that wish to exit now rather than holding their shares for the two years plus it would likely take to achieve a potentially higher realisation value for the businesses.
Sinclair Pharma - Aesthetically Positioned to Continue Double-Digit Growth
23 Mar 17
With an innovative and differentiated product portfolio of injectable devices addressing the fast-growing aesthetics market, Sinclair is best positioned to continue to achieve double-digit revenue growth in the medium term.